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news.Hybrigenics, a bio-pharmaceutical group with a focus on research and development of new cancer treatments and a fully-owned subsidiary specialised in protein interactions services, has filed a patent application covering new soft gelatin capsules, tablets or drinking solutions optimised for the delivery of high doses of inecalcitol.
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This pharmaceutical optimisation followed the demonstration of safety and the presumption of efficacy of oral doses as high as 4mg of inecalcitol per day in a Phase IIa clinical tolerance study in hormone-refractory prostate cancer patients.
All microdosed vitamin D analogues are currently marketed as oily solutions in soft gelatin capsules.
Hybrigenics claimed that Inecalcitol has recently been successfully formulated as 2mg tablets.
Drinking solutions of inecalcitol in a liquid excipient could provide complete dose proportionality to body weight, for any putative pediatric indications for example.
Pharmaceutical stability and human bioavailability studies in healthy volunteers are ongoing with an objective to start Phase IIb efficacy clinical trials in hormone-refractory prostate cancer and severe psoriasis with an already optimised formulation suitable for future commercialisation.
Hybrigenics CEO Remi Delansorne said that they have worked hard to reduce the size of soft gel capsules and to make tablets feasible, against all odds.
"Moreover, we believe they are new and inventive for a vitamin D analogue such as inecalcitol, paving the road for patent protection until 2030," Delansorne said.